Surgical Procedures for the Treatment of Stress Urinary Incontinence (SUI) in the Light of the Updated FDA-Warning and its Effects on Practice Patterns in Germany between 2010 and 2021

Author:

Naumann Gert12,Huebner Markus345ORCID,Taran Florin-Andrei3,Tunn Ralf6,Reisenauer Christl57,Neis Felix57ORCID

Affiliation:

1. Department of Gynecology and Obstetrics, Helios Hospital Erfurt, Erfurt, Germany

2. Department of Obstetrics and Gynecology, University of Düsseldorf, Düsseldorf, Germany

3. Department of Obstetrics and Gynecology, Medical Center – University of Freiburg, Freiburg, Germany

4. Faculty of Medicine, University of Freiburg, Freiburg, Germany

5. Faculty of Medicine, University of Tübingen, Tübingen, Germany

6. Department of Urogynecology, German Pelvic Floor Center, St. Hedwig Hospital, Berlin, Germany

7. Department of Womenʼs Health, University Hospital of Tübingen, Tübingen, Germany

Abstract

AbstractChanges in surgical practice patterns to cure stress urinary incontinence (SUI) became evident after FDA warnings regarding vaginal mesh were issued. The primary aim was to describe nationwide numbers of suburethral alloplastic slings (SAS) inserted in 2010, 2015, 2018 and 2021 in Germany. Secondary, numbers were related to SUI specific non-alloplastic alternatives and bulking agents. Additionally, age distribution and overall inpatient surgeries in women were subject to analysis.Descriptive study utilizing data gathered from the German Federal Statistical Office (www.destatis.de). Included were the following procedures of inpatient surgery: A. SAS; B. non-allplastic slings; C. open/laparoscopic colposuspension; D. Bulking agents; overall changes and changes in age distribution (groups of 5-years intervals) are described.Overall, n = 3599466 female inpatient procedures were analyzed. There was a considerable decrease of SAS surgeries of 28.49% between 2010 (n = 23464) and 2015 (n = 16778), and a decrease of 12.42% between 2015 and 2018 (n = 14695) and an additional decrease of 40.66% between 2018 and 2021 (n = 8720). Over time a 55.03% continuous decrease in non-alloplastic slings was observed (n = 725 in 2010 to n = 326 in 2021). Open and laparoscopic colposuspension numbers went down with a rate of 58.23% (n = 4415 in 2010, n = 1844 in 2021). Between 2010 and 2018, only bulking agent procedures increased with a rate of 5.89% from n = 1425 to n = 1509.There was a considerable decrease in inpatient surgical procedures using SAS. Alternatives not only failed to compensate, but experienced also a major decline.

Publisher

Georg Thieme Verlag KG

Reference25 articles.

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